A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
Recruiting
Phase 3
Interventional Study
Chickenpox
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 12 Months – 15 Months
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,840 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
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About This Trial
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor receive…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant's parent(s) Legally acceptable representatives /(LAR\[s\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
* Written or witnessed/thumb printed info…
Contacts